Commission Implementing Regulation (EU) 2021/843 of 26 May 2021 renewing the approval of the active substance cyazofamid, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011 (Text with EEA relevance)

• CELEX: Implementing Regulation (EU) 2021/843
• Articles: 5

Article 1 Renewal of the approval of the active substance

The approval of the active substance cyazofamid, as specified in Annex I, is renewed subject to the conditions laid down in that Annex.

Article 2 Amendments to Implementing Regulation (EU) No 540/2011

The Annex to Implementing Regulation (EU) No 540/2011 is amended in accordance with Annex II to this Regulation.

Article 3 Entry into force and date of application

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union .

It shall apply from 1 August 2021.

Schedules & Appendices

ANNEX I

ANNEX I

Common Name, Identification Numbers

IUPAC Name

Purity    ( 1 )

Date of approval

Expiration of approval

Specific provisions

Cyazofamid

CAS No: 120116-88-3

CIPAC No: 653

4-chloro-2-cyano-N,N-dimethyl-5-p-tolylimidazole-1-sulfonamide

≥ 935 g/kg

1.8.2021

31.7.2036

For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on cyazofamid, and in particular Appendices I and II thereto, shall be taken into account.

In this overall assessment Member States shall pay particular attention to:

(a)

the specification of the technical material as commercially manufactured;

(b)

the impact of processing on the consumer risk assessment;

(c)

the protection of non-target arthropods and earthworms.

The applicant shall submit to the Commission, the Member States and the Authority confirmatory information as regards:

1.

the effect of water treatment processes on the nature of residues present in surface water and groundwater, when surface water or groundwater is abstracted for drinking water;

2.

points 3.6.5 and 3.8.2 of Annex II of Regulation (EC) No 1107/2009, as amended by Commission Regulation (EU) 2018/605.

The applicant shall submit the requested information referred to in point 1 within two years from the date of publication by the Commission, of a guidance document on evaluation of the effect of water treatment processes on the nature of residues present in surface and groundwater.

As regards point 2, the applicant shall provide an updated assessment of the information already submitted and, where relevant, further information to confirm the absence of endocrine activity by 16 June 2023.

( 1 )   Further details on the identity and the specification of the active substance are provided in the renewal report.

ANNEX II

ANNEX II

The Annex to Commission Implementing Regulation (EU) No 540/2011 is amended as follows:

(1)

in Part A, entry 46 on cyazofamid is deleted;

(2)

in Part B, the following entry is added:

No

Common Name, Identification Numbers

IUPAC Name

Purity    ( 1 )

Date of approval

Expiration of approval

Specific provisions

‘146

Cyazofamid

CAS No: 120116-88-3

CIPAC No: 653

4-chloro-2-cyano-N,N-dimethyl-5-p-tolylimidazole-1-sulfonamide

≥ 935 g/kg

01/08/2021

31/07/2036

For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on cyazofamid, and in particular Appendices I and II thereto, shall be taken into account.

In this overall assessment Member States shall pay particular attention to:

(a)

the specification of the technical material as commercially manufactured;

(b)

the impact of processing on the consumer risk assessment;

(c)

the protection of non-target arthropods and earthworms.

The applicant shall submit to the Commission, the Member States and the Authority confirmatory information as regards:

1.

the effect of water treatment processes on the nature of residues present in surface water and groundwater, when surface water or groundwater is abstracted for drinking water;

2.

points 3.6.5 and 3.8.2 of Annex II of Regulation (EC) No 1107/2009, as amended by Commission Regulation (EU) 2018/605.

The applicant shall submit the requested information referred to in point 1 within two years from the date of publication by the Commission, of a guidance document on evaluation of the effect of water treatment processes on the nature of residues present in surface and groundwater.

As regards point 2 the applicant shall provide an updated assessment of the information already submitted and, where relevant, further information to confirm the absence of endocrine activity by 16 June 2023’

( 1 )   Further details on the identity and the specification of the active substance are provided in the renewal report.